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Insulin
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Cat. No.:
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KAI-071
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Type:
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Reagent
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Method:
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Immunoturbidimetric
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Format:
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Liquid
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Linearity:
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1 - 100 µIU/mL
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Sample:
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Serum, Plasma
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KIT COMPOSITION
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INTENDED USE
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For the quantitative determination of human insulin in serum and plasma by immunoturbidimetric assay.
FOR IN VITRO DIAGNOSTIC USE.
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REAGENT PREPARATION
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The reagents are ready to use and do not require reconstitution.
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STORAGE AND HANDLING
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All reagents should be stored refrigerated (2-8°C). Return all reagents to
2-8°C promptly after use. Unopened reagents can be used for one year from the
date of manufacture, as indicated by the expiration date on the package and bottle
labels. Opened reagents can be used for one month if stored at 2-8°C.
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PERFORMANCE
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Precision
The within-run, between-run, and total precision for the
K-ASSAY ®
Insulin assay was determined using packaged reagents, human serum samples, and a Roche / Hitachi 917 analyzer.
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Precision - Within Run
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Sample I
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Sample II
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Sample III
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N = 10
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N = 10
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N = 10
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Mean = 18.81
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Mean = 27.82
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Mean = 73.17
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S.D. = 0.224
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S.D. = 0.192
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S.D. = 0.760
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C.V. = 1.19%
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C.V. = 0.69%
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C.V. = 1.04%
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Precision - Between Runs
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Sample I
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Sample II
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Sample III
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N = 10
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N = 10
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N = 10
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Mean = 12.21
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Mean = 25.9
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Mean = 68.74
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S.D. = 0.530
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S.D. = 0.777
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S.D. = 1.693
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C.V. = 4.34%
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C.V. = 3.00%
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C.V. = 2.46%
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Accuracy / Correlation
A comparison of the
K-ASSAY ®
Insulin assay and another company's Insulin EIA was performed with the following results:
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Serum Samples:
y = 0.8061x + 2.8674
r = 0.997
n = 32
x = another company's Insulin assay
y = K-ASSAY ® Insulin Assay
Plasma Samples:
y = 0.8161x + 4.5552
r = 0.986
n = 47
x = another company's Insulin assay
y = K-ASSAY ® Insulin Assay
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Assay Range
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INTERFERENCE
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No cross-reactivity with pro-insulin was observed.
Hemoglobin, bile, or rheumatoid factor did not interefere
with the assay.
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Bilirubin F :
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No interference up to 19.3 mg/dL
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Bilirubin C :
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No interference up to 19.9 mg/dL
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Hemoglobin :
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No interference up to 450 mg/dL
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Lipemia :
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No interference up to a formazin turbidity of 1,550
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RF :
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No interference up to 450 IU/mL
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